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Generic Dextenza Availability

Last updated on July 7, 2021.

Dextenza is a brand name of dexamethasone ophthalmic, approved by the FDA in the following formulation(s):

DEXTENZA (dexamethasone - insert;ophthalmic)

  • Manufacturer: OCULAR THERAPEUTIX
    Approval date: November 30, 2018
    Strength(s): 0.4MG [RLD]

Has a generic version of Dextenza been approved?

No. There is currently no therapeutically equivalent version of Dextenza available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dextenza. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Drug delivery through hydrogel plugs
    Patent 8,409,606
    Issued: April 2, 2013
    Assignee(s): Incept, LLC

    An embodiment is a medical prosthesis for blocking or reducing tear flow through a punctum or canaliculus of a human eye and delivering a drug to the eye that comprises a dehydrated covalently crosslinked synthetic hydrophilic polymer hydrogel with dimensions to pass through a puncta lacrimali, with the dehydrated hydrogel absorbing physiological water to swell to at least 1 mm in cross-sectional width and conformably fit a canaliculus, with the hydrogel comprising a therapeutic agent dispersed through the hydrogel for release to an eye, with the hydrogel having a water content of at least about 50% by weight or volume when allowed to fully hydrate in vitro in physiological saline.

    Patent expiration dates:

    • May 14, 2030
      ✓ 
      Drug product
  • Drug delivery through hydrogel plugs
    Patent 8,563,027
    Issued: October 22, 2013
    Assignee(s): Incept, LLC

    An embodiment is a medical prosthesis for blocking or reducing tear flow through a punctum or canaliculus of a human eye and delivering a drug to the eye that comprises a dehydrated covalently crosslinked synthetic hydrophilic polymer hydrogel with dimensions to pass through a puncta lacrimali, with the dehydrated hydrogel absorbing physiological water to swell to at least 1 mm in cross-sectional width and conformably fit a canaliculus, with the hydrogel comprising a therapeutic agent dispersed through the hydrogel for release to an eye, with the hydrogel having a water content of at least about 50% by weight or volume when allowed to fully hydrate in vitro in physiological saline.

    Patent expiration dates:

    • February 12, 2030
      ✓ 
      Patent use: DEXTENZA IS APPROVED FOR THE TREATMENT OF OCULAR PAIN FOLLOWING OPHTHALMIC SURGERY
  • Composite hydrogel drug delivery systems
    Patent 9,254,267
    Issued: February 9, 2016
    Assignee(s): Incept, LLC

    Compositions and methods are provided to control the release of relatively low molecular weight therapeutic species through hydrogels by first dispersing or dissolving such therapeutic species within relatively hydrophobic rate modifying agents to form a mixture. The mixture is formed into microparticles that are dispersed within bioabsorbable hydrogels, so as to release the water soluble therapeutic agents in a controlled fashion. Methods of using the compositions of the present invention in therapeutic systems are also provided.

    Patent expiration dates:

    • September 11, 2024
      ✓ 
      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • November 30, 2021 - NEW PRODUCT
    • June 20, 2022 - TREATMENT OF OCULAR INFLAMMATION FOLLOWING OPHTHALMIC SURGERY

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.